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CompletedNCT07805161Updated Sep 4, 2026

Bipolar RFA Versus Phenol Neurolysis for Knee Osteoarthritis Pain

An interventional study of Phenol Chemical Neurolysis and Ultrasound-Guided Bipolar Radiofrequency Ablation in Gonarthrosis, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This prospective observational comparative study evaluates the analgesic efficacy and safety of ultrasound-guided bipolar radiofrequency ablation (BPRFA) versus phenol chemical neurolysis (PCN) of the genicular nerves in patients with chronic knee osteoarthritis (gonarthrosis) refractory to conservative treatment.

Patients with moderate-to-severe chronic knee pain who demonstrate significant pain relief following diagnostic genicular nerve block undergo either BPRFA or PCN targeting the superior medial, superior lateral, and inferior medial genicular nerves under ultrasound guidance. Pain intensity and functional outcomes are assessed using the Numeric Rating Scale (NRS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and during follow-up evaluations at 4, 12, and 24 weeks after treatment.

The study aims to compare pain reduction, functional improvement, responder rates, and procedure-related adverse events between the two treatment modalities.

Read the detailed description

Knee osteoarthritis (gonarthrosis) is a common cause of chronic knee pain and functional limitation, especially in older adults. Although conservative treatments such as physical therapy, oral analgesics, and intra-articular injections are commonly used, many patients continue to experience persistent pain and reduced quality of life. In recent years, minimally invasive genicular nerve interventions have become important alternatives for patients who do not achieve adequate benefit from conservative management or are not suitable candidates for surgery.

Radiofrequency ablation (RFA) of the genicular nerves has been shown to reduce pain and improve function in patients with chronic knee osteoarthritis. Bipolar radiofrequency ablation (BPRFA), which uses two closely positioned radiofrequency cannulas, may create larger lesions and provide broader denervation compared with conventional monopolar techniques. Phenol chemical neurolysis (PCN) is another minimally invasive treatment option that provides chemical denervation of the genicular nerves and may represent a simpler and more cost-effective alternative. However, concerns remain regarding the potential for unintended spread of phenol and procedure-related complications.

The aim of this prospective observational comparative study is to compare the analgesic efficacy, functional outcomes, and safety profiles of ultrasound-guided BPRFA and PCN in patients with chronic knee osteoarthritis who are refractory to conservative treatment. Patients with chronic moderate-to-severe unilateral knee pain and radiologically confirmed osteoarthritis first undergo diagnostic genicular nerve block under ultrasound guidance. Patients who achieve significant pain relief after the diagnostic block subsequently receive either BPRFA or PCN as part of routine clinical practice.

Pain severity and functional status are evaluated using the Numeric Rating Scale (NRS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and during follow-up visits at 4, 12, and 24 weeks after treatment. The study also compares treatment response rates and procedure-related adverse events between the two interventions.

02

Conditions studied

  • Gonarthrosis

Keywords

  • knee
  • gonarthrosis
  • radiofrequency ablation
  • phenol
  • ultrasound
  • genicular nerves
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults aged 18 to 75 years
  • Unilateral moderate-to-severe knee pain due to gonarthrosis
  • Numeric Rating Scale (NRS) score ≥6
  • Knee pain lasting longer than 6 months
  • Radiological diagnosis of knee osteoarthritis, Kellgren-Lawrence grade 2-4
  • Failure of conservative treatments, including analgesic medications, physical therapy, or intra-articular injections
  • At least 50% pain relief after diagnostic genicular nerve block
  • Ability to provide written informed consent

Exclusion criteria

Exclusion Criteria:

  • Knee pain due to causes other than osteoarthritis, such as fracture, trauma, spinal disorder, or inflammatory arthritis
  • Previous knee surgery
  • Knee joint effusion detected on physical examination or ultrasound
  • Cognitive impairment
  • Hepatic or renal failure
  • Severe psychiatric disorder
  • Local or systemic infection
  • Coagulopathy
  • Current use of antiplatelet or anticoagulant therapy
  • Presence of a pacemaker
  • Intra-articular injection or interventional knee procedure within the previous 6 months
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Active comparator
    Phenol Chemical Neurolysis

    Patients undergo ultrasound-guided phenol chemical neurolysis of the superior medial, superior lateral, and inferior medial genicular nerves following a positive diagnostic genicular nerve block.

    Procedure: Phenol Chemical Neurolysis

  • Active comparator
    Bipolar Radiofrequency Ablation

    Patients undergo ultrasound-guided bipolar radiofrequency ablation of the superior medial, superior lateral, and inferior medial genicular nerves following a positive diagnostic genicular nerve block.

    Procedure: Ultrasound-Guided Bipolar Radiofrequency Ablation

Interventions

  • ProcedurePhenol Chemical Neurolysis

    Ultrasound-guided phenol neurolysis was performed targeting the superior medial, superior lateral, and inferior medial genicular nerves. Following confirmation of needle placement, 2 mL of 8% phenol was injected around each targeted genicular nerve.

  • ProcedureUltrasound-Guided Bipolar Radiofrequency Ablation

    Ultrasound-guided bipolar radiofrequency ablation was performed using two parallel radiofrequency cannulas placed within 1 cm of each other targeting the superior medial, superior lateral, and inferior medial genicular nerves. Radiofrequency ablation was applied at 80°C for 90 seconds following sensory and motor stimulation testing.

05

What researchers measure

Primary outcomes

  1. Change in Pain Intensity

    Pain intensity was assessed using the Numeric Rating Scale (NRS). Changes in NRS scores from baseline were evaluated after ultrasound-guided bipolar radiofrequency ablation and phenol chemical neurolysis of the genicular nerves.

    Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks

Secondary outcomes

  1. Functional improvement

    Functional outcomes and quality of life were evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), including total, pain, stiffness, and function subscale scores.

    Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks

  2. Proportion of Patients Achieving ≥50% Reduction in NRS Scores

    Treatment response was defined as a reduction of at least 50% in Numeric Rating Scale (NRS) scores compared with baseline values following treatment.

    Time frame: 12 weeks and 24 weeks

  3. Procedure-related complications

    The incidence of procedure-related adverse events and complications was recorded throughout the follow-up period.

    Time frame: Up to 24 weeks

06

Study locations

1 site
  • University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology
    Ankara, Etlik 06010, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07805161
Lead sponsor
Saglik Bilimleri Universitesi
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Aug 1, 2024
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025
Last update
Sep 4, 2026

Study contacts

Alp Eren Celenlioglu, MD./Assoc. Prof.
study director · Department of Algology, University of Health Sciences Gulhane Training and Research Hospital, Ankara, Turkiye

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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